Overview
Quality Engineer I/Day Shift, x10s Jobs in Salt Lake City, Utah, USA at BioFire Diagnostics
Position: Quality Engineer I (Day Shift, 4 x10s)
Position Summary:
This is a full-time exempt position. The Quality Engineer I is responsible for assisting with the maintenance of Bio Fire Quality Assurance technical systems and continuous improvement programs.
This position plays a key role in providing feedback for the design, implementation, and processing of technical systems, including CAPA, NCR, and Quality Plans. The individual will work with Bio Fire employees outside of QA daily and must maintain a customer-focused attitude. They represent QA on complex technical and process issues, acting as an advisor to resolve problems, support specialty experts, and guide process compliance.
Primary
Duties
:
Perform work in compliance with company policy and Bio Fire Diagnostics’ Quality System.
Support NCR, CAPA, and other programs to ensure processes and compliance issues are addressed promptly.
Assist teams with investigation methodologies and validation strategies.
Help with note-taking, action item recording, follow-up, and communication to senior leaders as needed.
Study and report on project metrics.
Perform other duties as assigned.
Training,
Education & Experience:
Required:
Bachelor’s Degree in a related field.
ASQ Certified Quality Engineer and/or Certified Six Sigma Green Belt is a plus.
Experience with Quality Management Systems compliant with FDA – CFR, ISO 13485, ISO 9000, and CMDR.
Application of Continuous Improvement and QA tools (Pareto, flow charts, Ishikawa, process capability, histogram, etc.) is a plus.
Knowledge, Skills & Abilities:
Development of trends and measures.
Procedure writing and flowcharting.
Creating and delivering training presentations.
Attention to detail.
Strong written and verbal communication skills.
Ability to communicate with statisticians and perform statistical calculations; seek help when needed.
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Title: Quality Engineer I/Day Shift, x10s
Company: BioFire Diagnostics
Location: Salt Lake City, Utah, USA
Category: Quality Assurance – QA/QC (Quality Engineering), Engineering (Quality Engineering)
